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CompletedNCT03279991PLATONEUpdated Nov 14, 2023

Neuromed- Integrated Health Life Platform and Biobank

An observational study in Cardiovascular Diseases, Neuro-Degenerative Disease and Cancer, sponsored by Neuromed IRCCS. Completed at 1 site in Italy. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-11-14.

Sponsored by Neuromed IRCCS · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
4,000
Ages
19 Years and older
Sex
All
01

Study summary

This project aims to create a digital platform for personal, clinical, diagnostic and environmental data collection, management and analysis of patients with cardiovascular and neurological disease or cancer admitted to the Neuromed Group clinics, associated with a biobanks of biological fluids and human tissues and a biotechnological platform for "omics" analysis, to encourage personalized, preventative and predictive care.

Read the detailed description

There is a need for a change of vision in health care that could become a key innovation point for digital medicine in the future, a sort of Copernican revolution: the starting point is no longer the disease, but the patient around whom pathologies and risk factors rotate, not as distinct and uniquely defined entities, but as communicating and interconnected possibilities that define their form only in relation to the individual, his genome, his personality, his habits of life and the environment in which he lives. From these interactions, a personalized, dynamic, integrated, and continuous diagnostic and therapeutic pathway is created that accompanies the person not only in the stage of the disease but also in the previous and subsequent phases, becoming a way of life oriented towards the health of the person rather than a way to cure a disease.

An Integrated Health Life Platform enables you to develop an interactive healthcare health model among all actors who manage the health of the person, healthcare professionals in the area, and hospitals, caregivers, and community through the integration of remote monitoring of data with A virtual community.

The platform is thought not as a pure aggregation of data, but as a digital hub centered on the patient, with his (clinical and personal) data, but also the environment in which he lives, his behaviors, accessibility to services and The relationships that come to them and from them. The platform aims to effectively integrate self management, personalization of the path, and co-production of health, demonstrating that these three key dimensions of care are mutually reinforcing.

02

Conditions studied

  • Cardiovascular Diseases
  • Neuro-Degenerative Disease
  • Cancer
  • Pregnancy

Keywords

  • biobank
  • chronic disease
  • omics
  • big data
  • 4 P medicine
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients admitted in the Neuromed group clinics who will have signed informed consent

Inclusion criteria

  • Men and women
  • Older than 18 years
  • Cardiovascular disease
  • neurodegenerative disease
  • Cancer
  • Pregnancy

Exclusion criteria

Exclusion Criteria:

  • Inability to understand and to want
  • Refusal to sign the informed consent
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
4,000 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. Biological sample bank

    A repository of biological samples, "Neurobiobank", from patients who will join the project, will be organised at the biotechnology park of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Neuromed of Pozzilli under the responsibility of the experienced staff at the Department of Epidemiology and Prevention.

    Time frame: baseline

  2. Integrated health-life big data platform

    Analytical tools will be developped for integrating structured and unstructured patients data sets and derive actionable information from their observed interrelationships.

    Time frame: baseline

  3. omics analysis

    Measure of genomic, epigenetic and proteomic fingerprint of recruited patients

    Time frame: baseline

  4. Four P (4P) medicine

    Identification of patterns within the health data that correlate with disease or wellness and create personalised pathway of prevention and care.

    Time frame: Baseline

06

Study locations

1 site
  • IRCCS INM Neuromed, Department of Epidemiology and Prevention
    Pozzilli, IS 86077, Italy
07

References and documents

Publications

  • GBD 2015 SDG Collaborators. Measuring the health-related Sustainable Development Goals in 188 countries: a baseline analysis from the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1813-1850. doi: 10.1016/S0140-6736(16)31467-2. Epub 2016 Sep 21. Erratum In: Lancet. 2017 Jan 7;389(10064):e1. doi: 10.1016/S0140-6736(16)32610-1. PubMed 27665228 ↗
  • Iacoviello L, De Curtis A, Donati MB, de Gaetano G. Biobanks for cardiovascular epidemiology and prevention. Future Cardiol. 2014 Mar;10(2):243-54. doi: 10.2217/fca.13.110. PubMed 24762252 ↗
  • Fortier I, Doiron D, Burton P, Raina P. Invited commentary: consolidating data harmonization--how to obtain quality and applicability? Am J Epidemiol. 2011 Aug 1;174(3):261-4; author reply 265-6. doi: 10.1093/aje/kwr194. Epub 2011 Jul 11. PubMed 21749975 ↗
  • Kim DH, Kim YS, Son NI, Kang CK, Kim AR. Recent omics technologies and their emerging applications for personalised medicine. IET Syst Biol. 2017 Jun;11(3):87-98. doi: 10.1049/iet-syb.2016.0016. PubMed 28518059 ↗
  • Duffy MJ, O'Donovan N, McDermott E, Crown J. Validated biomarkers: The key to precision treatment in patients with breast cancer. Breast. 2016 Oct;29:192-201. doi: 10.1016/j.breast.2016.07.009. Epub 2016 Aug 9. PubMed 27521224 ↗

Individual participant data

Plan to share: Yes — submission of a research proposal form to be approved by the Moli-sani scientific committee and signature of a research agreement.

Supporting information: Study protocol, Icf, Csr

08

Registry details

Key details

Study ID
NCT03279991
Lead sponsor
Neuromed IRCCS
Responsible party
Licia Iacoviello (Professor, Neuromed IRCCS) — Principal investigator
First posted
Sep 12, 2017
Start date
Mar 4, 2019
Primary completion
Feb 27, 2023
Completion
May 30, 2023
Last update
Nov 14, 2023

Study contacts

licia Iacoviello, MD, PhD
study chair · IRCCS Neuromed

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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